ClearanceBrief
510(k) K261028 ยท FYA Gown, Surgical

Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)

ApplicantYadu Medical (Henan) Co., Ltd., He Nan, CN
DecisionSubstantially Equivalent, Aug 7, 2026
ReceivedMar 30, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K261028

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.